Application 013295
- Type
- NDA
- Sponsor
- LIEBEL-FLARSHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CONRAY | IOTHALAMATE MEGLUMINE | INJECTABLE;INJECTION | 60% | Yes | Yes |
| 002 | CONRAY 43 | IOTHALAMATE MEGLUMINE | INJECTABLE;INJECTION | 43% | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0019-0953 | Conray | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |
| 0019-0953 | Conray | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |
| 0019-0953 | Conray | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |
| 0019-0953 | Conray | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |
| 0019-3183 | Conray 43 | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |
| 0019-3183 | Conray 43 | iothalamate meglumine | Liebel-Flarsheim Company LLC | NDA | Current |